Lupin gets tentative nod from USFDA for generic Sugammadex injection

New Delhi: Pharma major Lupin Ltd on Tuesday said it has received tentative approval from the US health regulator for its generic version of Sugammadex injection used for reversing the effects of muscle relaxants given during surgery.

The tentative approval by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application for Sugammadex Injection of strengths 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL) single-dose vial, Lupin said in a regulatory filing.

The USFDA has tentatively approved Lupin's Sugammadex injection of the specified strengths as bioequivalent to Merck's Bridion injection, it added.


It is used for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults and pediatric patients aged 2 years and older undergoing surgery, the company said.